BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3854716 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11592
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED TO CLINIC WITH LOW R-WAVES, LOSS OF CAPTURE, AND A LOW PACING LEAD IMPEDANCE DUE TO SUSPECTED MICRO-DISLODGEMENT. WHEN REPOSITIONING WAS UNSUCCESSFUL, THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331097 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention